Patent Foramen Ovale

Migraine is a common chronic neurological condition linked to patent foramen ovale (PFO), a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.

Researchers are evaluating the safety and performance of Abbott's Structural Heart devices used in routine hospital practices and standard-of-care procedures for patients with various heart conditions such as atrial septal defect, muscular ventricular septal defect, patent foramen ovale, and valvular heart disease. This observational registry collects real-world data to meet regulatory requirements, including the European Union Medical Device Regulations 2017/745, which mandate active post-market follow-up of commercially available devices. The study includes patients who undergo implant attempts with Abbott Structural Heart devices like the Amplatzer Occlusion Devices and Epic Surgical Tissue Heart Valve devices. Patients may be enrolled before or shortly after their procedure, with different timelines depending on the device used. Follow-up visits align with each site's routine standard-of-care schedules and can be conducted in person, by phone, or virtually. Follow-up durations vary by device, ranging from discharge or 7 days post-procedure up to 10 years to monitor device performance and safety. Participants will provide informed consent and undergo data collection during their follow-up visits, which may include routine clinical assessments and monitoring consistent with standard care. The study tracks primary safety and effectiveness endpoints at 7 days and baseline, respectively. Approximately 500 subjects are expected to enroll each year across about 25 sites worldwide, and some sub-studies focus on specific surgical valve sizes. The total participation duration varies based on device type and follow-up requirements.

Researchers are gathering real-world information on patient outcomes and evaluating the performance and success of the CeraFlex15 PFO Closure System, a device designed to close Patent Foramen Ovale (PFO) without surgery. This multicenter, prospective, observational study is open-label and post-market, aiming to understand how well this device works in everyday medical practice. Participants will receive the Lifetech CeraFlex PFO closure system, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The device is applied through a catheter-based procedure to close the PFO. After enrollment over about 18 months, each participant will be followed for 24 months after the procedure to monitor outcomes and device performance. Throughout the study, participants will have assessments at hospital discharge, then at 1 to 3 months, 6 months, 12 months, and 24 months post-procedure. Data on procedural success, residual shunt, stroke events, device issues, serious adverse events, and death will be collected and analyzed. An electronic data capture system will be used to securely collect study information.

This trial investigates the safety of stopping antithrombotic treatment 12 months after successful transcatheter closure of a patent foramen ovale (PFO) in young patients who have had a cryptogenic stroke or transient ischemic attack (TIA). The study focuses on patients aged 18 to 60 years without other major risk factors, aiming to find out if shorter antiplatelet therapy after PFO closure reduces bleeding risks without increasing stroke or ischemic events. Participants will all have undergone successful PFO closure and will follow a plan to discontinue antiplatelet treatment 12 months after the procedure. Clinical evaluations and brain MRI scans are performed at 12 months (before stopping treatment) and again at 24 months post-PFO closure to monitor for new ischemic lesions or stroke events. During the study, participants will be closely monitored through clinical assessments and MRI imaging to detect any new strokes or ischemic brain lesions. Researchers will track the number and volume of new cerebral ischemic lesions and ischemic events over follow-ups extending up to 10 years, as well as bleeding rates. The total participation duration includes evaluations at 12 and 24 months, with continued monitoring of outcomes for several years.

This clinical trial is studying patients who have a small opening between the upper chambers of the heart, called a Patent Foramen Ovale (PFO), and who have experienced a stroke possibly related to this heart condition. The trial aims to evaluate the safety and effectiveness of a new heart device called the Recross P3 Occluder System for closing the PFO to reduce the risk of future strokes. The study involves implanting the Recross P3 Occluder device into the heart using a minimally invasive procedure to close the PFO. After implantation, participants will have follow-up visits with their doctors at 1 month, 3 months, 6 months, 1 year, and 5 years to monitor their condition and the device. Additionally, study staff will call participants at 2, 3, and 4 years after the procedure to conduct surveys. Participants will undergo exams, including brain imaging to confirm stroke, and heart imaging to evaluate device position and closure effectiveness. The main outcomes measured include the rate of major cardiovascular events at 30 days and the success of PFO closure at 6 months. Safety is monitored through rates of serious adverse events related to the device or procedure. The total participation may last up to 5 years with regular check-ups and long-term follow-up calls.

Patent Foramen Ovale (PFO) is a common heart defect that may be linked to migraines, especially migraine with aura. Researchers are studying how PFO affects the brain's glymphatic system and its connection to migraine symptoms. They aim to understand if closing the PFO can improve migraines and glymphatic function, using a case-control design to compare patients with and without migraine who have PFO with significant right-to-left shunt. The study involves two groups: one with PFO and migraine who receive a minimally invasive percutaneous PFO closure procedure, and a control group with PFO but no migraine who do not receive closure. The closure uses a device inserted through a catheter to seal the PFO tunnel under imaging guidance. Both groups undergo assessments of migraine symptoms and glymphatic function before and six months after intervention or enrollment. Participants will be monitored for changes in migraine frequency and pain intensity, using tools like the Monthly Migraine Days and Visual Analogue Scale for pain. Glymphatic function is measured by imaging indexes such as the DTI-ALPS. The study takes place over at least six months post-procedure or enrollment, with the goal of understanding the effects and mechanisms of PFO closure on migraine and brain function.

Researchers are evaluating the safety, effectiveness, and noninferiority of the Encore PFO closure device compared to any FDA-approved PFO closure device chosen by investigators. The study focuses on patients who have had a cryptogenic stroke caused by a presumed paradoxical embolism and involves closing a patent foramen ovale (PFO) through a percutaneous, transcatheter procedure. This prospective, multicenter, randomized clinical study aims to provide reasonable assurance of the Encore device's safety and effectiveness. Participants will be randomly assigned to receive either the Encore PFO closure device, which includes an implant component and a single-use delivery system, or an FDA-approved PFO closure device selected by the investigator. The procedure involves using these devices to close the PFO via catheter-based delivery. The study design includes comparison of procedural and device-related outcomes between these two groups. During the study, participants will be monitored for safety, including the incidence of serious adverse events related to the device or procedure within 6 months. Effectiveness will be assessed by measuring the success of PFO closure at 6 months. Additional evaluations include long-term monitoring for recurrent stroke, transient ischemic attacks, new atrial arrhythmias, and procedural success over 5 years. Participants will undergo imaging, neurological assessments, and follow-up visits to track outcomes and overall safety throughout the study period.

Researchers are establishing a headache center in China to study migraine patients who also have patent foramen ovale (PFO). The study aims to explore different treatment options for this combination, identify factors that may influence outcomes, and develop models to predict prognosis. The goal is to improve understanding and care for patients with both conditions. Participants will be assigned to one of three groups based on treatment approach: a conservative group that does not use antiplatelet drugs or undergo PFO closure surgery, a group that receives antiplatelet drug treatment, and a group that undergoes PFO closure surgery. The study is observational and will follow patients over time to monitor their condition. During the study, participants will be regularly monitored for changes in migraine attacks at 3 months, 6 months, 1 year, 2 years, and 3 years. The study involves clinical, imaging, and laboratory examinations to gather detailed information. Participants will be followed up to assess the effects of their treatment approach and factors influencing migraine outcomes with PFO.

Researchers are evaluating the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults with patent foramen ovale (PFO) who have experienced an ischemic stroke. This post-approval study also looks at how well operator education and training transfer to real-world medical settings. The goal is to understand device performance and patient outcomes over time in a broader patient population. Participants will receive the GORE4 CARDIOFORM Septal Occluder device for PFO closure. This is a single-arm study using a commercially available device. After the implant procedure, participants will be followed up at 1 month, 6 months, 12 months, and then annually for up to 5 years to monitor device success and safety. The study focuses on detecting any recurrent strokes, device-related serious adverse events, and effectiveness of PFO closure. During the study, participants will undergo regular medical assessments including echocardiographic evaluations to assess PFO closure and check for any residual shunting. Researchers will also monitor for new atrial arrhythmias and record procedural success. Follow-up visits will include clinical evaluations and safety monitoring. The primary outcomes include the proportion of patients with recurrent ischemic stroke over 24 months and device- or procedure-related serious adverse events within 30 days post-implant. The total participation may last up to 5 years post-procedure to ensure long-term data collection.

Researchers are studying the internal structure of patent foramen ovale (PFO), a heart condition linked to cryptogenic stroke, transient ischemic attack (TIA), and migraine. The study aims to understand how the microstructure of PFO relates to these conditions and to assess the effectiveness of closing the PFO with a catheter-based procedure. It also includes examining asymptomatic PFO patients and analyzing blood samples to explore related metabolic features. The study includes three groups: patients with PFO who have had a stroke or TIA and undergo closure, patients with PFO and migraine who also undergo closure, and asymptomatic patients with PFO who are followed for five years without closure. Blood samples are collected from various heart and vessel sites, and cardiac CT angiography (CTA) is used to evaluate device placement and shape. Participants will be monitored through clinical evaluations and blood tests, including metabolomics analysis from the right and left atrium. Researchers record symptoms during a test where blood is transferred between heart chambers. The main outcome measured is adverse events over five years after assessing the PFO's internal microstructure. This helps understand risks and guide treatment decisions for PFO-related conditions.